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The 1VQ papers advocate for the idea that certain post-approval changes should be streamlined and expedited.
Post-approval changes (PACs) are inextricable sequelae of living in the real world. “They are inevitable and necessary throughout the life of a drug product—to implement new knowledge, maintain a state of control, and drive continual improvement … Many PACs require regulatory agency approval by individual countries before implementation. Because of the global regulatory complexity, individual PACs usually take years for full worldwide approval even when they reduce patient risk, improve compliance, or enhance the manufacturing process or test methods” (1).
A modification to a vaccine, sold in a dozen different countries, can require more than 100 new approvals. If successfully handled by a robust internal (and already well proven) pharmaceutical quality system (PQS) to manage these modifications, time, energy, and money—for both the manufacturer and also the regulators—would be saved. Both BioPharm International and Pharmaceutical Technology have published a series of position papers on this topic. They cover “Change of Lot or Extension of Shelf-life of Reference Standard”, “Change in Size of Thermal Shipping Solution Used for Transport of Product”, and “Addition of a Testing Lab to an Existing Testing Site,” among other facets.
The 2022 Parenteral Drug Association (PDA)-FDA Joint Regulatory Conference in Washington, DC truly showcased how well industry stakeholders can communicate and cooperate. Sufficient trust has been established, one would think, such that some of these product modifications can be managed in a streamlined and expedited fashion. Particularly since these positions are proposed by senior quality leaders (chief quality officers and heads of quality) from more than 20 global pharmaceutical companies, and “are speaking with “One-Voice-Of-Quality” (1VQ) to advocate for an effective management of specific PACs that currently are handled as a prior-approval change in some countries, but where a standard science and risk-based approach concludes that these should be downgraded to a notification or handled only in the PQS (2).
Special mention should be given to Emma Ramnarine, Global Head, External Development Collaborations at Genentech/Roche, and Anders Vinther, VP Quality at Kronos Bio, for galvanizing action in this field.
Mike Hennessy Jr. is the President and CEO of MJH Life Sciences.
Vol. 35, No. 10
When referring to this article, please cite it as M. Hennessy, "Optimizing Quality," BioPharm International 35 (10) 8 (2022).